Covaxin has been given approval in clinical trial mode

As soon as DCGI gave its nod to Bharat Biotech’s Covaxin, people raised concerns about its efficacy as the vaccine has been cleared on the basis of its safety and immunogenicity data. Its efficacy data has not been published yet. 

To clear the air around the approval of the vaccine, Dr Balram Bhargava, chief of Indian Council of Medical Research (ICMR), said on Tuesday that Bharat Biotech’s Covid-19 vaccine has been cleared in the clinical trial mode, which means consent of participants has to be taken. 

Explaining the process followed in granting approval to Oxford University-AstraZeneca’s Covashield and ICMR-Bharat Biotech’s developed Covaxin, Bhargava said, “The existing pandemic situation, high mortality, available science and lack of definitive treatments were considered by the subject expert committee (SEC) on Covid-19 of CDSCO for granting accelerated approval to these vaccines, and that is in our legal provision.”

The Drugs Controller General of India (DCGI) approved two vaccines for restricted emergency use in the country. Some doctors, scientists, and political leaders have raised concern over the absence of Phase-III trial data on Bharat Biotech’s Covaxin. 

Quoting a  special clause, Dr Bhargav said, “The Clinical Trial Rule, 2019, provides for considering phase two results to guide approval. Now the SEC guides the DCGI in the process of decision making for restricted use under emergency situation. Now we have two vaccines,” Bhargava said.

Union health secretary Rajesh Bhushan also said that the ministry is prepared to roll out Covid-19 vaccine within 10 days.